Clinical Trial: Pediatric Blunt Abdominal Trauma Clinical Prediction Model
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]
Official Title: Multicenter, Prospective Development of a Clinical Prediction Model to Determine Which Children Can Safely Avoid Abdominal CT Scanning During the Initial Evaluation of Blunt Abdo
Brief Summary: The submitted proposal is designed to reduce morbidity and mortality to injured children. Significant variability in the initial trauma assessment exists among institutions. The proposed project is a prospective, observational, multi-institutional study of children following blunt abdominal trauma. The specific goals of the project are to: 1) Document history, physical exam findings, imaging, and laboratory values, which are available to physicians during the initial trauma resuscitation prior to a decision on whether to order an abdominal computed tomography (CT) to evaluate for potential intra-abdominal injury; and 2) Derive and validate a multi-variable clinical prediction rule based on data variables readily available during the pediatric trauma resuscitation to identify patients at low risk for intra-abdominal injury, in which unnecessary CT might safely be avoided. Information from this study could be used to develop a more standardized approach to the evaluation for intra-abdominal injury following blunt trauma in children. This information could lead to significant improvement in the early recognition of injury and to improved resource utilization.
Detailed Summary:
The proposed research project is a prospective, observational study. Data will be collected from each institution and entered into a secure REDCap database. Two phases of data collection will occur: 1) patient demographics and specific clinical variables which may be associated with IAI which are available and recorded during the initial trauma evaluation 2) laboratory and imaging results available after the initial assessment, identified injuries, patient disposition, interventions and outcomes.
Primary Outcome Variables: 1) Intra-abdominal injury (IAI) (presence of solid or hollow organ injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular structure, bladder, ureter, gallbladder, abdominal wall fascia)) 2) IAI requiring intervention (abdominal operation, angio-embolization, blood transfusion)
Time Course: The initial data collection period will extend for one year. Data will be recorded in a password protected redcap database which is readily available online to all participating institutions.
Study setting: Eleven Level One Pediatric Trauma Centers
Data collection points: demographics (age, mechanism, alert level), physical exam, labs (AST, HCT, amylase, UA, base deficit), FAST, imaging results, injuries, outcomes (admission, ICU admit, need for intervention, missed injuries, ISS).
Data Analysis: De-identified data will be used during the data analysis phase to minimize the risk of loss of confidentiality to the patients. Data analysis with development of a clinical prediction rule (CPM) will be performed as follows. A logistic regression will be used to fit a predictive model for both IAI and IAI requiring interventions. SAS 9.3 will be used
Sponsor: Medical University of South Carolina
Current Primary Outcome:
- Intra-abdominal Injury (IAI) [ Time Frame: 30 days from time of trauma ]Intra-abdominal injury (IAI) (presence of solid or hollow organ injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular structure, bladder, ureter, gallbladder, abdominal wall fascia))
- Intraabdominal Injury (IAI) requiring intervention [ Time Frame: 30 days from time of trauma ]Intra-abdominal injury (IAI) requiring intervention (Laparoscopy or Laparotomy, angio-embolization, blood transfusion for IAI)
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medical University of South Carolina
Dates:
Date Received: July 31, 2014
Date Started: July 2014
Date Completion: January 2016
Last Updated: May 14, 2015
Last Verified: April 2015
